IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La— 510(k) K253817

Name: FDA 510(k) clearance K253817
Creator: U.S. Food and Drug Administration
Published: 2026-08-21

Substantially Equivalent

Immunodiagnostics Systems Limited

FDA 510(k) clearance K253817 for IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La, Substantially Equivalent on 2026-08-21. Applicant: Immunodiagnostics Systems Limited. Device class: 2.

Summary

Immunodiagnostics Systems' submission lists three assays: IDS SS-A/Ro, IDS SS-A/Ro 60 kDa, and IDS SS-B/La. They're filed under product code LLL, extractable antinuclear antibody antigen and control.

Class II, 21 CFR 866.5100. Immunology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

The applicant filed from Boldon, United Kingdom. The decision came 266 calendar days after receipt (November 28, 2025 to August 21, 2026), and it was substantially equivalent.

Clearance details

Applicant: Immunodiagnostics Systems Limited
Product code: Product code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2025-11-28
Decision date: 2026-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boldon, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.